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Quality Engineer - II (Medical Device)

Req ID: J2260517

  • Ubicación
    West Chester, Pensilvania, United States of America
  • Categoría Grupo de Calidad
  • Publicado martes, 11 de mayo de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

Jabil Brandywine campus is located in West Chester, PA. We are proud to manufacture Medical Devices for orthopedic specialties including trauma, spine, and specialty implants for leading medical technology companies. Our employees are honored to work together with industry leading companies to make a difference in the lives of patients around the world.

SUMMARY
Represent the quality function of technical support, in conjunction with other internal support groups, regarding issues affecting manufacturing.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Understand & follow site safety policies and procedures related to work activities performed in area of responsibility and actively promote a safety culture.

• Support attainment of key business metrics through the provision of Quality Engineering support for value stream processes.
• Study the effectiveness of inspection activities.
• Design means for measuring accuracy and documenting of inspection work.
• Recommend and evaluate inspection gauges and test equipment.
• Perform root cause analysis for product defects and quality processes.
• Provide day-to-day Quality Engineering support for Quality Systems and Manufacturing departments.
• Implement process control systems.
• Provide Quality and Manufacturing technical support for component, product and process validations.
• Provide Quality and Manufacturing technical support for new product transfer.
• Coordinate training of manufacturing associates as applicable.
• Establish and maintain appropriate documentation as required for Quality Systems activities.
• Quality team member participating in New Product Introduction process.
• Participate in Customer Complaint investigation process. 
• Support Nonconformance & CAPA investigations and actions to determine root cause and corrective actions as needed.

• Support day to day operations through attendance at CAC, TIC, MIC and QIC meetings and the timely closure of assigned actions. 

• Provide support to the team in Root Cause Analysis of supply and quality issues as they arise through tools such as 8D, A3, and Six Sigma.
• Project Management - provide timely and accurate reporting on project activities ensuring projects are delivered to agreed timelines.
• Perform Statistical Analysis, including:  ANOVA, DOE, Weibull, GR&R, Capability, FMEA, and TMVs as required.
• Participate in validation process for manufacturing processes, gauges, inspection equipment, software and computerized systems as required.
• Prepare written protocols as necessary.
• Provide leadership to QS organization through continuous improvement & cost reduction projects.
• Interface with manufacturing area and other support groups to ensure department objectives are met.
• Follow all company safety policies and other safety precautions within the work area.
• Promote safety to all associates and complete required safety training.

·   Participate and support with Internal / External Quality / Regulatory Audit process. 

·   Adhere to the site’s EHS Code of Conduct.

·   Evaluate and/or design sampling plans and process control plans for lot acceptance and control processes.

Other responsibilities may be assigned and not all responsibilities listed may be assigned.


MANAGEMENT & SUPERVISORY RESPONSIBILITIES

• Job is not responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• Report to Site Quality Engineering Manager or Quality Engineering Leader


JOB QUALIFICATIONS & KNOWLEDGE REQUIREMENTS


• Excellent written and oral skills and the ability to organize and follow up on multiple, concurrent priorities.
• Able to make solid decisions that will effectively support the business and company policies.
• Able to work in a self-paced environment and provide leadership to team as appropriate.
• Team player.
• Project Management skills. 
• Able to understand application of regulatory requirements to the business.
• Able to analyze and develop quality methods. Responsible for writing clear and concise protocols, study reports, and procedures.
• This position requires consistent involvement with and knowledge of changes in regulations and standards.
• Aptitude to respond to shifting priorities through appropriate realignment of required tasks. Personal computers Proficiency required.
• Skilled in use of PC based systems including, but not limited to statistical tools, inventory management, complaints handling, non-conforming product systems and data base management, and document change management systems.


MINIMUM REQUIREMENTS
Bachelor's degree required and two years related experience; or equivalent combination of education and experience.

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